Real-World Treatment Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor as First Line Therapy in Post-Menopausal Women and Men With Metastatic Breast Cancer (P-REALITY 3)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  IBRANCE
• Study drug International non-proprietary name (INN) or common name:
  PALBOCICLIB
• Medical condition to be studied:
  Breast cancer metastatic

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  2000

Study design details

• Main study objective:
  To compare OS in postmenopausal women and men treated with palbociclib + AI versus AI alone as first-line therapy for HR+/HER2- MBC
• Outcomes:
  Overall Survival in postmenopausal women and men treated with palbociclib + AI versus AI alone as first-line therapy for HR+/HER2- MBC, rwPFS and rwRR in post-menopausal women and men treated with palbociclib + AI versus AI alone as first-line therapy for HR+/HER2 - MBC during first-line treatment
• Data analysis plan:
  An IPTW approach will be used to compare palbociclib + AI versus AI alone for the average treatment effect (ATE) on the primary endpoint OS. A weighted log-rank test with the robust variance estimation will be used for the hypothesis testing with the significance level at 1-sided 0.025. Hazard ratio (HR) for OS with the corresponding 2-sided 95% CI will be calculated based on a weighted Cox’s proportional hazard model.